Back to resultsThe Evaluation of a Novel Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Nasal Pillows CPAP mask
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- Adult (18+ years of age)
- Able to give consent
- Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
- Prescribed PAP for OSA
- Existing nasal pillows mask user
Exclusion Criteria:
- Inability to give consent
- Patients who are in a coma or a decreased level of consciousness
- Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
- Commercial drivers who are investigated by New Zealand Transport Agency
- Current diagnosis of carbon dioxide (CO2) retention
- Pregnant or may think they are pregnant
Sites / Locations
- Fisher & Paykel Helathcare
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Trial Continuous Positive Airway Pressure (CPAP) mask
Arm Description
Trial nasal pillows CPAP mask
Outcomes
Primary Outcome Measures
Ease of use
Subjective Questionnaire
Acceptability
Subjective Questionnaire
Secondary Outcome Measures
Objective Leak Data
Data obtained from participant's device - Objective
Full Information
NCT ID
NCT03605485
First Posted
July 22, 2018
Last Updated
August 13, 2018
Sponsor
Fisher and Paykel Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT03605485
Brief Title
The Evaluation of a Novel Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
Official Title
The Evaluation of a Novel Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 7, 2018 (Actual)
Primary Completion Date
August 10, 2018 (Actual)
Study Completion Date
August 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F&P trial nasal pillows mask amongst Obstructive Sleep Apnea (OSA) participants.
Detailed Description
Visit 1 will involve the participants consented in to the trial. Participants will be fitted with the F&P trial nasal pillows mask for use in-lab.
The participant will then return the mask and have a interview, this ensures the maximum time participants will be exposed to the trial mask in lab will be in 1 night.
The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all participants within 1 week of the beginning of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trial Continuous Positive Airway Pressure (CPAP) mask
Arm Type
Experimental
Arm Description
Trial nasal pillows CPAP mask
Intervention Type
Device
Intervention Name(s)
Nasal Pillows CPAP mask
Intervention Description
Investigative Nasal pillows Mask to be used for OSA therapy
Primary Outcome Measure Information:
Title
Ease of use
Description
Subjective Questionnaire
Time Frame
1 night
Title
Acceptability
Description
Subjective Questionnaire
Time Frame
1 night
Secondary Outcome Measure Information:
Title
Objective Leak Data
Description
Data obtained from participant's device - Objective
Time Frame
1 night
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult (18+ years of age)
Able to give consent
Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
Prescribed PAP for OSA
Existing nasal pillows mask user
Exclusion Criteria:
Inability to give consent
Patients who are in a coma or a decreased level of consciousness
Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
Commercial drivers who are investigated by New Zealand Transport Agency
Current diagnosis of carbon dioxide (CO2) retention
Pregnant or may think they are pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bhavi Ogra
Organizational Affiliation
Employee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fisher & Paykel Helathcare
City
Auckland
Country
New Zealand
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Evaluation of a Novel Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
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